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Flexion Biosciences, Inc.
Osteoarthritis pain
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Current therapies: either lubricant or have severe adverse effects
HPA (hypothalamic-pituitary-adrenal) axis suppression and
hyperglycemia (GC: Kenalog)
Lubricant (Hyaluronic acid): not much therapeutic effect
Oral administration for knee pain (NSAIDs): GI and cardiovascular
adverse effects (AEs); have to use the lowest effective dose for the
shortest duration
Take up to 7 days to work for arthritis pain (Motrin gel)
Addictive (Opioids)
NSAIDs-induced small intestinal
damage
Problems of current therapies
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Our proposal having three folds of advantages
New product
Dual (anti-inflammatory and analgesic) action: therapeutics
No or minimal HPA/hyperglycemia: intra-articular injection
Extended release: 3-month/injection
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The market > billions
Rheumatoid arthritis market size: $53.1b
(https://www.ihealthcareanalyst.com/global-rheumatoid-arthritis-drugs-market/)
Joint pain market size: >$5b in 2023; topical pain relief market $10.5b in 2023; and post operative
pain market $35.5b in 2022.
(https://www.polarismarketresearch.com/industry-analysis/joint-pain-injections-market)
https://www.precedenceresearch.com/joint-pain-injections-market
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IP patentable with practical de-risked strategies
Intellectual property (IP): ways to cover with patents
Novel chemical entity (NCE)
NCE with PLGA composites
Production process (NCE and composite)
Strategies to approach
Intra-articular injection to limit systemic AEs
Prodrugs of current active drugs to lower the regulatory hurdle and de-risk development path
Competitive edges
Safer vs available therapies
Dual actions
Longer therapy (3-month)
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New product expected to be dominant vs competitors
Hyaluronic acid (HA): lubricant; possible CD44/RHAMM modulation and tissue
regeneration/angiogenesis factor: Triluron , and (Hyalectin®)
Analgesic/anti-inflammatory NSAIDs: oral, GI adverse effects and cardiovascular issues:
Voltaren, Naproxen, Celecoxib, etc.
Anti-inflammatory glucocorticoid steroids (GCs): oral and intra-articular: severe HPA axis
suppression and hyperglycemia: Kenalog® (triamcinolone acetonide) for injection;
Zilretta® (extended-release TCA/PLGA microspheres); Zilretta (TCA/PLGA): net sales
105.5m (2022), 111.1m (2023).
Opioids: effective but generally controlled/limited use
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Fund to raise and one-year plans
Seeking pre-seed/seed:
$60k: make 5-8 proto compounds
$200k: confirm the dose reduction potential of the proto compounds in vivo
$800k: prepare sustained release form and analyze blood drug concentration for HPA axis
suppression and hyperglycemia in animal model, efficacy and non-GLP tox.
Main tasks
\month, 2024 6 7 8 9 10 11 12 1/25 2 3 4 5
Proto 5
-8 compounds synthesis: $60k
Assay set
-up and evaluation of stability, and biomarker:
$200k
Complete knee and blood PK: $200k
Microparticle prep
, and encapsulation and PK: $200k
$200k
Optimization of ratio, linker: $200k
In vivo efficacy: $200k
Non
-GLP tox: $200k
Project review
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Project questions answered
1: Is the product much better than the existing products?
The product will be the best osteoarthritis pain therapy: efficacious, safer (with minimal HPA
axis suppression and hyperglycemia, etc.) and long action.
2: Can you find and market the product to the users of the product?
About 21.2% of all adults, or 53.2m people in US, have arthritis. Market size is >billions.
3: Is the market growing?
According to multiple sources, CABG at high digit %.
4: Is the product defendable?
Yes, new NCE. Patent has been drafted.
5: Can you get the team, knowledge and capital to build the product?
Yes, the path has been paved, but it may require $40-50m to go through clinical phases 1-2a
for IPO.
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SWOT analysis
StrengthsS
oValidated biology, SAR clear, and markets, known regulatory path, product profile superior vs
competitors.
WeaknessesW
oStart late, no commercial team
OpportunitiesO
oBest product in huge market will have a dominant share
oFuture IPO/licensing
oLow risk
ThreatsT
oNo sufficient fund for IND, IPO, or phase 2a-3.
Palo Alto, CA